BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHILEY

    MDR report key: 23376165 · Received October 23, 2025

    Report

    Report Number
    9681384-2025-01128
    Event Type
    Malfunction
    Date Received
    October 23, 2025
    Date of Event
    October 13, 2025
    Report Date
    October 23, 2025
    Manufacturer
    COVIDIEN AG JUAREZ (MMJ)
    Product Code
    JOH
    UDI-DI
    60884522007028
    PMA / PMN Number
    K962173
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D10 CONCOMITANT PRODUCTS: 6FEN, 6FEN 6 CUFF FEN TRACH CANN REUS ICX1, (LOT# 25D0428JZX) 6FEN, 6FEN 6 CUFF FEN TRACH CANN REUS ICX1, (LOT# 25D0428JZX) 6FEN, 6FEN 6 CUFF FEN TRACH CANN REUS ICX1, (LOT# 25D0428JZX) 6FEN, 6FEN 6 CUFF FEN TRACH CANN REUS ICX1, (LOT# 25D0428JZX) 6FEN, 6FEN 6 CUFF FEN TRACH CANN REUS ICX1, (LOT# 25D0428JZX) 6FEN, 6FEN 6 CUFF FEN TRACH CANN REUS ICX1, (LOT# 25D0428JZX) 6FEN, 6FEN 6 CUFF FEN TRACH CANN REUS ICX1, (LOT# 25D0428JZX) 6FEN, 6FEN 6 CUFF FEN TRACH CANN REUS ICX1, (LOT# 25D0428JZX) MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE INNER CANNULAS OF THE NINE TRACHEOSTOMY TUBES HAD AN UNEVEN END. THERE WAS NO PATIENT INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1402215 SHILEY TUBE TRACHEOSTOMY AND TUBE CUFF JOH COVIDIEN AG JUAREZ (MMJ) 6FEN 25D0428JZX 60884522007028

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown SEE H11